Cleared Special

K020096 - ESTHETIC EASE ABUTMENTS FOR THE ITI DEN...

K020096 is the FDA 510(k) clearance for ESTHETIC EASE ABUTMENTS FOR THE ITI DEN... by Institut Straumann AG. It is a Class 2 Dental device (product code DZE) cleared through the Special 510(k) pathway after a 28-day FDA review.

K020096 · Institut Straumann AG · Dental device
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Feb 2002
Decision
28d
Days
Class 2
Risk

K020096 is an FDA 510(k) clearance for the ESTHETIC EASE ABUTMENTS FOR THE ITI DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Waltham, US). The FDA issued a Cleared decision on February 8, 2002 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Institut Straumann AG devices

Submission Details

510(k) Number K020096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2002
Decision Date February 08, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 127d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 610
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K020096.
VIDENT HEXTOP, SYNOCTA IN-CERAM BLANK/COPING MANUFACTURED BY VIDENT
K012473 · Vident · Sep 2002
OSSEOTITE NT DENTAL IMPLANTS & ACCESSORIES
K014235 · Implant Innovations, Inc. · May 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020645 · BioHorizons Implant Systems, Inc. · Mar 2002
SYNOCTA ANGLED ABUTMENTS FOR THE ITI WIDE NECK IMPLANT
K013891 · Institut Straumann AG · Feb 2002
MODIFICATION TO THE MAESTRO SYSTEM
K020133 · BioHorizons Implant Systems, Inc. · Jan 2002
PROSTHETIC ACCESSORIES TO THE ITI DENTAL IMPLANT SYSTEM
K013798 · Institut Straumann AG · Dec 2001